In a significant move for the life sciences sector, two industry leaders have joined forces to tackle one of clinical research's most persistent and expensive challenges: inefficient trial protocol design. Citeline, a global provider of clinical intelligence solutions, and Swiss-based Risklick, an AI specialist for protocol development, announced a strategic partnership on January 13, 2026.
The High Cost of Protocol Amendments
The collaboration addresses a critical pain point for pharmaceutical and biotech sponsors. Industry data shows a substantial increase in protocol amendments since 2015. Each amendment is not just a bureaucratic hurdle; it carries a staggering financial burden, with costs ranging from $140,000 to $500,000. These delays and redesigns slow down the entire drug development pipeline, ultimately postponing potential treatments for patients.
The new partnership aims to create a holistic, digital solution that spans the entire protocol lifecycle—from initial design and authoring to operational execution and regulatory disclosure. By integrating their technologies, the companies promise to move sponsors from concept to execution faster than ever before.
Combining Data Intelligence with Digital Workflow
The core of the solution lies in merging Citeline's vast repository of clinical trial data and artificial intelligence models with Risklick's end-to-end digital protocol workflow. Citeline will leverage its data on successful trials, biomarkers, real-world patient information, and proprietary sponsor data to provide evidence-based optimization for key protocol components.
"We are transforming protocol design from a manual hurdle into a high-speed, AI-driven engine," stated Suzanne Caruso, General Manager of Citeline Strategic Intelligence, Clinical & Regulatory. "By embedding our best-in-class data directly into a digitized workflow, sponsors can accelerate their timelines significantly."
Risklick contributes its purpose-built AI platform, which digitizes the entire protocol development process. Its AI assistant specializes in early-stage trial design and literature analysis, working from a user-defined knowledge base to streamline the initial phases of study planning.
A Vision for One-Day Clinical Study Design
The partnership has an ambitious ultimate goal. Dr. Poorya Amini, Founder and CEO of Risklick, articulated a vision to radically speed up clinical research: "Our mission is to enable the pharmaceutical industry to design a clinical study in just one day. This partnership with Citeline is a key step toward making that vision a reality."
The combined offering is designed to produce optimally designed, patient-centered protocols. The expected outcomes for research sponsors include:
- Reduced operational and financial risk from amendments.
- Accelerated trial timelines from concept to execution.
- Improved patient enrollment outcomes through smarter protocol design.
- More predictable and efficient clinical trials overall.
The collaboration between Citeline, a Norstella company, and Risklick represents a major step in the digital transformation of clinical development. By creating a fully connected digital trial ecosystem, they aim to empower sponsors to build higher-quality protocols from the outset, saving critical time and resources in the race to bring new therapies to market.
